Anorexia Nervosa, Cancer
Conditions
Keywords
Auricular Needling, Mechanism Study, Anorexia, Cancer
Brief summary
Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It plays an important role in improving the quality of life among advanced cancer patients. Through a randomized controlled single blinded clinical research, we will observe the differences of appetite, food intake amount, weight and KPS between the auricular needling treating group and control group before and after the treatment. Based on the results of the research, we can prove the clinical effectiveness of auricular needling in treating cancer induced anorexia and possible mechanism of the method.
Detailed description
Patients will be recruited from Xiyuan Hospital. In this study, eligible participants will be randomly assigned to two groups. In the auricular needling treating group, patients will receive needling treating for 4 weeks(auricular needles are given to one ear every time for 2-3days,then switch to the other). Conventional nutrition support and symptomatic treatment are given at the same time. In the control group, patient just receive conventional nutrition support and symptomatic treatment. The simple appetite questionnaire, a symptom based Anorexia assessment questionnaire and fatigue symptom inventory questionnaire are used to assess the condition of patients. Other observation index include weight, KPS, appetite and the expectation of patients.
Interventions
OTHERauricular needling
Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Smallintestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of malignant cancer of stage III or IV * Meet the diagnosis criteria of cancer induced anorexia * Karnofsky performance status(KPS) score≥ 60 * Expected survival time≥3 months * Willing to give informed consent * Able to comply with trial protocol
Exclusion criteria
* have blood routine, hepatic and renal disfunction,which is over 2 times of the normal value * obvious eating disorder, intestinal obstruction, poor controlled heart disease and diabetes * who are receiving progesterone, glucocorticoid or other hormone Therapy * those who are participating in other trials. * pregnant women, nursing mother or psychotic patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simple Appetite Questionnaire | 10 weeks | The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess the patient's appetite.Possible scores range from 4（poor appetite) to20（good appetite）.The score lower than 14 predicts a risk of 5% weight loss. |
| Symptom Based Anorexia Assessment | 10 weeks | Symptom based anorexia assessment is used to evaluate whether and to what extent anorexia occurs in cancer patients.Possible scores range from 0(normal appetite) to 48(severe anorexia).After the patient answers all the questions in the table, the score is scored, and the final score is less than or equal to 24 points, which can be determined as anorexia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appetite Improvement | 10 weeks | The appetite improvement is used to indicates the patient's appetite.Method: Use a moving ruler about 10cm long, with one side marked with 10 scales, the two ends are 0 and 10 respectively, 0 means normal appetite, 10 scores indicate extreme aversion to food. When in use, the side with the scale should face away from the patient, and let the patient mark on the ruler.The corresponding position that can represent one's own desire for food, the position marked by the doctor according to the patient is its score, clinical evaluation is divided into normal appetite/basically normal eaters, 3-5 with 0-2. Divided into mild anorexia, 6-8 into moderate anorexia, \>8 into severe anorexia |
| Weight | 10 weeks | Weight used to assess the appetite of patient.Body weight changes caused by factors such as body cavity effusion and edema were excluded. Improvement: weight gain \> 2kg,and maintained for more than 4 weeks. Stable: Weight gain or loss ≤ 2kg. Exacerbation: Weight loss \> 2kg. |
| Acupuncture Treating Expectation Questionnaire | 10 weeks | Acupuncture treating expectation questionnaire used to assess patients' expectation for auricular needling.Higher scores indicate higher expectations.Possible scores range from 4（low expectations） to 20（high expectations). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Auricular Needling Group Patients will receive auricular needling for 4 weeks .
auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner. | 27 |
| Control Group This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week. | 28 |
| Total | 55 |
Baseline characteristics
| Characteristic | Auricular Needling Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 12 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 16 Participants | 26 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 7 | 63 years STANDARD_DEVIATION 13 | 65 years STANDARD_DEVIATION 11 |
| Body weight | 56.89 kg STANDARD_DEVIATION 10.04 | 58.47 kg STANDARD_DEVIATION 6.85 | 57.49 kg STANDARD_DEVIATION 8.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 28 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 27 participants | 28 participants | 55 participants |
| Sex: Female, Male Female | 17 Participants | 13 Participants | 30 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Simple Appetite Questionnaire
The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess the patient's appetite.Possible scores range from 4（poor appetite) to20（good appetite）.The score lower than 14 predicts a risk of 5% weight loss.
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Needling Group | Simple Appetite Questionnaire | Stop treatment for 4 weeks | 13.00 score on a scale | Standard Deviation 2.236 |
| Auricular Needling Group | Simple Appetite Questionnaire | Baseline | 8.7 score on a scale | Standard Deviation 1.996 |
| Auricular Needling Group | Simple Appetite Questionnaire | Treatment for 2 weeks | 11.26 score on a scale | Standard Deviation 2.246 |
| Auricular Needling Group | Simple Appetite Questionnaire | Treatment for 4 weeks | 13.19 score on a scale | Standard Deviation 2.058 |
| Control Group | Simple Appetite Questionnaire | Treatment for 4 weeks | 9.50 score on a scale | Standard Deviation 2.186 |
| Control Group | Simple Appetite Questionnaire | Stop treatment for 4 weeks | 9.68 score on a scale | Standard Deviation 2.161 |
| Control Group | Simple Appetite Questionnaire | Treatment for 2 weeks | 9.93 score on a scale | Standard Deviation 1.654 |
| Control Group | Simple Appetite Questionnaire | Baseline | 9.57 score on a scale | Standard Deviation 1.854 |
Primary
Symptom Based Anorexia Assessment
Symptom based anorexia assessment is used to evaluate whether and to what extent anorexia occurs in cancer patients.Possible scores range from 0(normal appetite) to 48(severe anorexia).After the patient answers all the questions in the table, the score is scored, and the final score is less than or equal to 24 points, which can be determined as anorexia.
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Needling Group | Symptom Based Anorexia Assessment | Baseline | 8.70 score on a scale | Standard Deviation 1.996 |
| Auricular Needling Group | Symptom Based Anorexia Assessment | Treatment for 2 weeks | 11.26 score on a scale | Standard Deviation 2.246 |
| Auricular Needling Group | Symptom Based Anorexia Assessment | Treatment for 4 weeks | 13.19 score on a scale | Standard Deviation 2.058 |
| Auricular Needling Group | Symptom Based Anorexia Assessment | Stop treatment for 4 weeks | 13.00 score on a scale | Standard Deviation 2.236 |
| Control Group | Symptom Based Anorexia Assessment | Stop treatment for 4 weeks | 9.68 score on a scale | Standard Deviation 2.161 |
| Control Group | Symptom Based Anorexia Assessment | Baseline | 9.57 score on a scale | Standard Deviation 1.854 |
| Control Group | Symptom Based Anorexia Assessment | Treatment for 4 weeks | 9.5 score on a scale | Standard Deviation 2.186 |
| Control Group | Symptom Based Anorexia Assessment | Treatment for 2 weeks | 9.93 score on a scale | Standard Deviation 1.654 |
Secondary
Acupuncture Treating Expectation Questionnaire
Acupuncture treating expectation questionnaire used to assess patients' expectation for auricular needling.Higher scores indicate higher expectations.Possible scores range from 4（low expectations） to 20（high expectations).
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Needling Group | Acupuncture Treating Expectation Questionnaire | baseline | 12.26 score on a scale | Standard Deviation 3.68 |
| Auricular Needling Group | Acupuncture Treating Expectation Questionnaire | Treatment for 2 weeks | 13.74 score on a scale | Standard Deviation 3.25 |
| Auricular Needling Group | Acupuncture Treating Expectation Questionnaire | Treatment for 4 weeks | 14.30 score on a scale | Standard Deviation 3.3 |
| Auricular Needling Group | Acupuncture Treating Expectation Questionnaire | Stop treatment for 4 weeks | 11.04 score on a scale | Standard Deviation 5.09 |
| Control Group | Acupuncture Treating Expectation Questionnaire | Stop treatment for 4 weeks | 7.57 score on a scale | Standard Deviation 4.02 |
| Control Group | Acupuncture Treating Expectation Questionnaire | baseline | 10.00 score on a scale | Standard Deviation 4.42 |
| Control Group | Acupuncture Treating Expectation Questionnaire | Treatment for 4 weeks | 9.04 score on a scale | Standard Deviation 4.38 |
| Control Group | Acupuncture Treating Expectation Questionnaire | Treatment for 2 weeks | 9.64 score on a scale | Standard Deviation 3.73 |
Secondary
Appetite Improvement
The appetite improvement is used to indicates the patient's appetite.Method: Use a moving ruler about 10cm long, with one side marked with 10 scales, the two ends are 0 and 10 respectively, 0 means normal appetite, 10 scores indicate extreme aversion to food. When in use, the side with the scale should face away from the patient, and let the patient mark on the ruler.The corresponding position that can represent one's own desire for food, the position marked by the doctor according to the patient is its score, clinical evaluation is divided into normal appetite/basically normal eaters, 3-5 with 0-2. Divided into mild anorexia, 6-8 into moderate anorexia, \>8 into severe anorexia
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Needling Group | Appetite Improvement | Baseline | 6.56 score on a scale | Standard Deviation 1.717 |
| Auricular Needling Group | Appetite Improvement | Treatment for 2 weeks | 4.56 score on a scale | Standard Deviation 2.172 |
| Auricular Needling Group | Appetite Improvement | Treatment for 4 weeks | 3.59 score on a scale | Standard Deviation 1.845 |
| Auricular Needling Group | Appetite Improvement | Stop treatment for 4 weeks | 3.30 score on a scale | Standard Deviation 1.918 |
| Control Group | Appetite Improvement | Stop treatment for 4 weeks | 5.75 score on a scale | Standard Deviation 1.818 |
| Control Group | Appetite Improvement | Baseline | 5.39 score on a scale | Standard Deviation 1.548 |
| Control Group | Appetite Improvement | Treatment for 4 weeks | 5.29 score on a scale | Standard Deviation 1.823 |
| Control Group | Appetite Improvement | Treatment for 2 weeks | 5.36 score on a scale | Standard Deviation 1.496 |
Secondary
Weight
Weight used to assess the appetite of patient.Body weight changes caused by factors such as body cavity effusion and edema were excluded. Improvement: weight gain \> 2kg,and maintained for more than 4 weeks. Stable: Weight gain or loss ≤ 2kg. Exacerbation: Weight loss \> 2kg.
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Needling Group | Weight | Baseline | 56.89 kg | Standard Deviation 10.04 |
| Auricular Needling Group | Weight | Treatment for 2 weeks | 57.32 kg | Standard Deviation 9.741 |
| Auricular Needling Group | Weight | Treatment for 4 weeks | 58.05 kg | Standard Deviation 9.998 |
| Auricular Needling Group | Weight | Stop treatment for 4 weeks | 58.08 kg | Standard Deviation 9.753 |
| Control Group | Weight | Stop treatment for 4 weeks | 57.54 kg | Standard Deviation 6.964 |
| Control Group | Weight | Baseline | 58.47 kg | Standard Deviation 6.851 |
| Control Group | Weight | Treatment for 4 weeks | 57.86 kg | Standard Deviation 6.751 |
| Control Group | Weight | Treatment for 2 weeks | 58.30 kg | Standard Deviation 6.922 |